FDA.reportPublic FDA data

Application 018200

Type
NDA
Sponsor
PADDOCK LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIDAMORAMILORIDE HYDROCHLORIDETABLET;ORAL5MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0574-0292amiloride hydroclorideamiloride hydrocloridePaddock Laboratories, LLCNDACurrent
0574-0292amiloride hydroclorideamiloride hydrocloridePadagis US LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
14943SUPPL2003-03-10
40782SUPPL2002-05-30
33455SUPPL2002-03-21
871SUPPL2002-03-21